| CTRI Number |
CTRI/2025/11/097360 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of hyperbaric ropivacaine drug effect when given in single shot spinal anesthesia versus low dose combined spinal epidural anaesthesia in patient groups having cardiac disease and undergoing hip fracture surgery. |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of hyperbaric ropivacaine in single dose spinal versus low dose combined spinal epidural anaesthesia among cardiac patients undergoing hip fracture surgery: A randomized comparative study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Udita Naithani |
| Designation |
Professor |
| Affiliation |
R.N.T medical college |
| Address |
Department of Anaesthesia, R.N.T Medical college, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829414752 |
| Fax |
|
| Email |
Uditanaithani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udita Naithani |
| Designation |
Professor |
| Affiliation |
R.N.T medical college |
| Address |
Department of Anaesthesia, R.N.T Medical college, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829414752 |
| Fax |
|
| Email |
Uditanaithani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeksha Chandra |
| Designation |
Pg Resident |
| Affiliation |
R.N.T Medical college |
| Address |
Department of Anaesthesia, R.N.T Medical college, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
7895147150 |
| Fax |
|
| Email |
deekshachandra96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, RNT Medical College, Udaipur, Rajasthan, 313001 |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Government Hospital |
| Address |
Department of Anaesthesia, R.N.T Medical college, Udaipur, Rajasthan 313001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Udita Naithani |
Maharana Bhupal Hospital |
Department of Orthopedics, Orthopedics operation theatre,Operating Room 1 and 2. 2nd floor, polytrauma Building, Maharana Bhupal hospital, RNT Medical College, Udaipur, Rajasthan 313001
Udaipur
RAJASTHAN |
9829414752
Uditanaithani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS, UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M899||Disorder of bone, unspecified, (2) ICD-10 Condition: W108||Fall (on) (from) other stairs andsteps, (3) ICD-10 Condition: W06||Fall from bed, (4) ICD-10 Condition: W07||Fall from chair, (5) ICD-10 Condition: W15||Fall from cliff, (6) ICD-10 Condition: S720||Fracture of head and neck of femur, (7) ICD-10 Condition: S720||Fracture of head and neck of femur, (8) ICD-10 Condition: S720||Fracture of head and neck of femur, (9) ICD-10 Condition: O||Medical and Surgical, (10) ICD-10 Condition: O||Medical and Surgical, (11) ICD-10 Condition: O||Medical and Surgical, (12) ICD-10 Condition: V235||Motorcycle passenger injured in collision with car, pick-up truck or van in traffic accident, (13) ICD-10 Condition: S710||Open wound of hip, (14) ICD-10 Condition: V011||Pedestrian injured in collision with pedal cycle in traffic accident, (15) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.75% hyperbaric ropivacaine in combined spinal epidural anaesthesia |
Patients will receive intrathecal injection of 1.75 ml 0.75% hyperbaric ropivacaine and 0.25 ml fentanyl (total 2ml)in L4-L5 space followed by injection of 6 ml 0.5% isobaric ropivacaine via epidural catheter after 5 minutes of intrathecal injection |
| Comparator Agent |
0.75% hyperbaric ropivacaine in single shot spinal anaesthesia |
Patients will receive subarachnoid block using intrathecal injection of 2.25 ml 0.75% hyperbaric ropivacaine and 0.25 ml fentanyl. |
| Intervention |
To compare the incidence of hypotension |
To determine the incidence of intraoperative hypotension for 150 minutes in patients receiving 0.75% hyperbaric ropivacaine in single shot spinal anesthesia compared with combined spinal epidural anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 18 years or above, of both sex, ASA grade 2 to 4, having preexisting cardiac disease and undergoing elective hip fracture surgery of expected duration of 2 hours |
|
| ExclusionCriteria |
| Details |
Any contraindications to spinal anesthesia, allergic to local anesthetics, patient refusal, if patient is converted to GA and pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of intraoperative hypotension |
To compare incidence of intraoperative hypotension at baseline, time of induction, at 3, 6,9 12, 15 , 20, 25, 30,35,40,45,50,55,60,75,90,105,120,135 and 150 minutes after induction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare sensory & motor block characteristics |
Sensory & motor block characteristics were noted at 3, 6, 9, 12, 15 & 20 minutes after induction |
| Hemodynamic profile including systolic BP,diastolic BP,Mean Arterial pressure, Heart Rate & oxygen saturation |
Hemodynamic vitals noted at baseline, time of induction, 3,6,9,12,15,20,25,30,35,40,45,50,55,60,75,90,105,120,135 & 150 minutes post induction |
| Adverse cardiac events occurring intraoperatively & postoperatively |
Adverse cardiac effects noted for 48 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hip fractures in elderly population are associated high mortality. Postoperative cardioevents are frequent accounting for around 40% of all reported complications among patients receiving hip fracture surgery. Most patients with hip fractures are fragile and preexisting CVD combined with acute trauma as well as surgical stress could potentially increase the risk of post operative cardiovascular events. Not many comparative studies of CSE versus single dose spinal anaesthesia using hyperbaric ropivacaine in cardiac patients undergoing hip fracture surgery to assess the effect on perioperative hypotension and adverse cardiac effects have been done.We are therefore planning to compare clinical efficacy and safety profile of 0.75% hyperbaric ropivacaine when administered in single dose spinal anesthesia versus low dose combined spinal epidural anesthesia in cardiac patients undergoing hip fracture surgeries. Primary outcome measuredwill be incidence of hypotension and secondary outcomes measured will be sensory-motor block characteristics , quality of anaesthesia, hemodynamic profile, adverse effects and adverse cardiac events occurring during first 48 hours. |